Comparison of Warfarin Initiation at 3 mg Versus 5 mg for Anticoagulation of Patients with Mechanical Mitral Valve Replacement Surgery: A Prospective Randomized Trial

• Published in: Clinical drug investigation 2022-04, Vol.42 (4), p.309-318
• Main Authors: Sabry, Sarah, El Wakeel, Lamia Mohamed, Saleh, Ayman, Ahmed, Marwa Adel
• Format: Article
• Language: English
• Subjects: Adjustment; Anticoagulants - therapeutic use; Clinical medicine; Drug Resistance; Enoxaparin - adverse effects; Heart; Hemorrhage - chemically induced; Hemorrhage - drug therapy; Hospitals; Humans; Internal Medicine; International Normalized Ratio; Laboratories; Medicine; Medicine & Public Health; Metabolism, Inborn Errors; Mitral Valve - surgery; Original; Original Research Article; Patients; Pharmacists; Pharmacology/Toxicology; Pharmacotherapy; Postoperative period; Prospective Studies; Prostheses; Single-Blind Method; Surgery; Thromboembolism; Warfarin - therapeutic use
• ISSN: 1173-2563; 1179-1918
• DOI: 10.1007/s40261-022-01137-7

Background The increased warfarin sensitivity observed after mechanical mitral valve replacement (MVR) operations dictates clinical discretion in warfarin dose initiation. Evidence is still lacking with regard to anticoagulation management of MVR patients. Objective This study aimed to compare initiating warfarin at the recommended dosing regimen versus empirically lowered doses intended to account for the variation in warfarin sensitivity. Methods A prospective, single-blind, randomized, comparative study was conducted in postoperative MVR patients. Patients were randomly assigned to either the 5 mg group ( n = 25) or the 3 mg group ( n = 25) and were initiated on a 5 or 3 mg warfarin dose, respectively. Time to target international normalized ratio (INR), time in therapeutic range, occurrence of bleeding/thromboembolic events, and cost of bridging with enoxaparin were assessed for both groups. Results Target INR was achieved earlier in the 5 mg group than in the 3 mg group ( p = 0.033), with a mean ± SD of 5.3 ± 2.0 and 6.6 ± 2.0, respectively (95% confidence interval of the mean difference 1.022–1.890). Bleeding events did not differ significantly between the two groups. The cost of enoxaparin consumption per patient was significantly higher in the 3 mg group versus the 5 mg group ( p = 0.002). Conclusions The initiation of warfarin at a 5 mg dose in MVR patients was more efficacious than the 3 mg dose in terms of time to reach the target INR. Moreover, the cost of enoxaparin bridging was significantly reduced with a 5 mg warfarin initiation dose. Bleeding events were comparable. ClinicalTrials.gov ID NCT04235569, 22 January 2020.